Table 1.
Assessment of Outcomes Using Claims Compared to Adjudicated Trial Data in the EXTEND-CoreValve Study
| Present in Claims* (N) | Present in Trial (N) | Sensitivity (%, 95% CI) | Specificity (%, 95% CI) | PPV (%, 95% CI) | NPV (%. 95% CI) | Kappa Coefficient (95% CI) | ||
|---|---|---|---|---|---|---|---|---|
| Yes | No | Total | ||||||
| Major clinical endpoints at 1 year | ||||||||
| Death †, ‡ | ||||||||
| Yes | 99.9 (99.2, 100.0) | 99.9 (99.8, 100.0) | 99.7 (98.9, 99.9) | 100.0 (99.8, 100.00) | 1.00 (0.99, 1.00) | |||
| No | ||||||||
| Total | ||||||||
| Aortic Valve Reintervention† | ||||||||
| Yes | 84.4 (70.5, 93.5) | 99.6 (99.4, 99.8) | 69.1 (57.8, 78.5) | 99.8 (99.7, 99.9) | 0.76 (0.66, 0.85) | |||
| No | ||||||||
| Total | ||||||||
| Myocardial Infarction | ||||||||
| Yes | 49 | 115 | 162 | 63.6 (51.9, 74.3) | 97.2 (96.7, 97.7) | 29.9 (25.0, 35.3) | 99.3 (99.1, 99.5) | 0.39 (0.31, 0.47) |
| No | 28 | 4054 | 4084 | |||||
| Total | 77 | 4169 | 4246 | |||||
| Procedural complications at 30 days | ||||||||
| Permanent Pacemaker Implantation | ||||||||
| Yes | 733 | 30 | 763 | 92.2 (90.1, 94.0) | 99.1 (98.8, 99.4) | 96.1 (94.5, 97.2) | 98.2 (97.7, 98.6) | 0.93 (0.91, 0.94) |
| No | 62 | 3405 | 3467 | |||||
| Total | 795 | 3435 | 4230 | |||||
| Acute Kidney Injury | ||||||||
| Yes | 346 | 560 | 906 | 70.2 (65.9, 74.2) | 85.4 (84.2, 86.5) | 38.2 (36.0, 40.5) | 95.7 (95.1, 96.2) | 0.41 (0.37, 0.44) |
| No | 147 | 3273 | 3420 | |||||
| Total | 493 | 3833 | 4326 | |||||
| Bleeding | ||||||||
| Yes | 1184 | 2201 | 3385 | 86.4 (84.5, 88.2) | 36.8 (35.2, 38.4) | 35.0 (34.2, 35.7) | 87.3 (85.7, 88.8) | 0.16 (0.14, 0.18) |
| No | 186 | 1281 | 1467 | |||||
| Total | 1370 | 3482 | 4852 | |||||
Sensitivity = (true positives)/(true positives + false negatives); specificity = (true negatives)/(true negatives + false positives); PPV = (true positives)/(true positives + false positives); NPV = (true negatives)/(true negatives + false negatives).
PPV=positive predictive value, NPV=negative predictive value, CI=confidence interval
The comprehensive code set was used to ascertain outcomes in claims.
Values for cell counts Not reported per the Centers for Medicare and Medicaid cell suppression policy.
Discrepancies between ascertainment of death in the trial and in CMS data stem from missing event(s) in CMS data, missing date information in trial data, or difference(s) in dates between the 2 data sources of > 14 days.